Diasorin announces FDA clearance for Simplexa COVID-19 / Flu A/B & RSV Direct kit
Designed for hospital and commercial labs, this sample-to-answer test simplifies respiratory virus detection, helping healthcare providers manage seasonal surges effectively.
Diasorin announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Simplexa COVID-19 / Flu A/B & RSV Direct kit, a sample-to-answer test for the detection of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) directly from nasopharyngeal and nasal swab specimens.
Designed for use on the LIAISON MDX system, the assay is suitable for both hospital and commercial laboratories, enabling timely and differential diagnosis of the 4 primary respiratory viruses circulating during the winter season in approximately 45 minutes. Following the COVID-19 pandemic, a resurgence of both influenza virus and RSV, particularly evident since the 2022/2023 season, has underscored the need to detect these pathogens, along with SARS-CoV-2, during peak infection periods. The Simplexa COVID-19 / Flu A/B & RSV Direct kit addresses this need by providing a streamlined solution that delivers accurate and simultaneous detection in a single assay.
